OTC HIV Test - FDA Considering Approval

The Food and Drug Administration (FDA) is reviewing the first ever test consumers could purchase over-the-counter to enable concerned individuals to test on their own -- at home and without having to see a doctor -- whether they have the HIV virus. Word is, the FDA is considering approving the test for consumers to purchase at a drug store or online.
The test is called the OraQuick In-Home HIV test, which reviewers think may help slow the spread of the HIV virus. This review comes just one day following an FDA panel approving the HIV pill called Truvada for HIV preventative use.
The concern over the approval with the at home HIV test lies in the concern over privacy. If the OraQuick In-Home HIV test is approved for OTC use, consumers would simply swab their mouth. The test would return a result in 20 minutes.
Experts estimate that roughly a quarter of million people in the United States out of the 1.2 million carriers of the HIV virus, don't even know they are infected. If these people were able to test in the privacy of their own homes, it could slow down the rate of infections. For the past twenty years, the new of new HIV infections has grown at a steady clip of about 50,000 new cases per year.
In a trial conducted to test the accuracy of the test, the test was correct in detecting the HIV virus in those carrying it 93 percent of the time, as conducted by the company OraSure Technologies, Inc. At 99 percent, the test was even better at accurately determining patients who didn't have the disease, which is well over the 95 percent recommended accuracy threshold the FDA advises.










